Medical Writer II, Oncology

Company Overview

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Learn more at

Medical Writer II, Regulatory Medical Writing – Oncology;
Integrated Data Analytics & Reporting (IDAR)

Job Function:
Medical Affairs Group | Job Sub Function:
Medical Writing | Job Category:
Professional

Possible locations:
Beerse, Belgium;
Leiden, The Netherlands;
High Wycombe/Maidenhead, UK;
Toronto, Canada;
Spring House / Titusville, United States.

Hybrid – 3 days onsite per week. Remote work options may be considered on a case‑by‑case basis and if approved by the company.

As Medical Writer II, Regulatory Medical Writing, you will support our Oncology therapeutic area within our Regulatory Medical Writing team, authoring diverse regulatory medical writing documents.

Develops within the medical writing role within the pharmaceutical industry. Works in a team environment and matrix. Performs routine tasks per established procedures. Gains knowledge and applies internal standards, regulatory, and publishing guidelines. With increasing skill, uses internal systems, tools, and processes. Writes and coordinates basic documents, preparing more complex documents (within the TA and across TAs) in accordance with experience level.

Functions as a lead writer on a project, indication, or a compound either early‑or late‑stage in life cycle under close supervision. Participates in process working groups.

• Writing and coordinating basic clinical documents such as, but not limited to, Phase1 protocols, Phase1/2 CSRs, table of studies, narratives, and initial IBs.
• Writing, contributing to, and/or coordinating low to medium complexity clinical and regulatory documents such as, but not limited to, Phase2/3 CSRs and protocols, IB updates, summary documents, and regulatory responses under supervision.
• Performing document QC, completing list of abbreviations or references, conducting literature searches, and performing other basic tasks with supervision as needed.
• Participating in and may be leading cross‑functional document planning and review meetings.
• Working in a team environment with some guidance while increasing independence for longer‑term activities.
• Taking an active role on assigned projects with respect to timing, scheduling, and tracking.
• Interacting with cross‑functional colleagues on document content and championing MW processes and best practices.
• Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.
• Guiding or training cross‑functional team members on processes and best practices.
• Leading early‑or late‑stage compound writing teams with supervision, as required.
• Learning and adhering to SOPs, templates, best practices, policies, Medical Writing Style Guide.
• Regularly meeting with manager and mentors and attending departmental meetings, cross‑functional meetings (eg, project kick‑off and review meetings, study team meetings, Global Program Team meetings).
• Completing all time reporting, training, and metrics database, and project tracking updates as required in relevant company systems.
• Maintaining and applying knowledge of industry, company, and regulatory guidelines.
• Mentoring more junior staff on document planning, processes, content, or providing peer review.

• A university/college degree in a scientific discipline is the minimum requirement, with an advanced degree (eg, Master’s…